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Validating an automated outcomes surveillance application using data from a terminated randomized, controlled trial
Michael E Matheny1, David A Morrow, Lucila Ohno-Machado
1Decision Systems Group, Brigham & Women's Hospital, Boston, MA, USA.
AMIA ... Annual Symposium Proceedings. AMIA Symposium
|August 13, 2008
Summary
An automated system (DELTA) was validated for outcomes surveillance using a clinical trial (OPUS) that was stopped early. The system’s methods, Statistical Process Control and Bayesian Updating Statistics, were compared to standard Data Safety Monitoring Board protocols.
Area of Science:
- Clinical trials methodology
- Health outcomes research
- Biostatistics
Background:
- Automated systems can enhance clinical trial monitoring.
- Early trial termination is critical for patient safety.
- Data Safety Monitoring Boards (DSMBs) oversee trial safety.
Purpose of the Study:
- To validate the DELTA automated outcomes surveillance system.
- To compare DELTA's methodologies with traditional DSMB protocols.
- To assess the utility of Statistical Process Control (SPC) and Bayesian Updating Statistics (BUS) in real-time trial monitoring.
Main Methods:
- Utilized data from the OPUS (TIMI-16) multi-center randomized controlled trial.
- Implemented and compared Statistical Process Control (SPC) and Bayesian Updating Statistics (BUS) within the DELTA system.
- Compared automated surveillance results against established DSMB protocols.
Main Results:
- The DELTA system demonstrated feasibility in outcomes surveillance.
- The study identified specific patterns of elevated mortality leading to early trial cessation.
- Comparison between DELTA and DSMB protocols highlighted potential differences in detection timelines.
Conclusions:
- Automated surveillance systems like DELTA show promise for enhancing patient safety in clinical trials.
- Methodologies such as SPC and BUS can provide valuable insights for early detection of adverse events.
- Further validation is needed to fully integrate automated systems alongside traditional DSMB oversight.
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